Quality Assurance Assistant Partner

PRTR

  • จตุจักร, กรุงเทพฯ
  • งานประจำ
  • ฟูลไทม์
  • 2 เดือนที่ผ่านมา
Job DescriptionMore than just a recruitment company. At PRTR, we have been a part of our customer's success for 30 years as their total HR solutions partner. With 550 dedicated professionals and over 15,000 outsourced staff, we will continue to carry out our mission to develop a better career, a better life, and a better society, and thrive to become the No.1 people solutions organization in Southeast Asia.Key Roles and Responsibilities
  • Quality Management System (QMS, GIP/GDPMD) and Compliance for DIA & DC
  • Supporting a team in implementing a new/updated Modular Quality Management System (MQMS) within timeline.
  • Assisting in conducting training sessions for new/updated MQMS modules and Global Standard procedures through the relevant functions and recording training participation in Cornerstone.
  • Monitoring training completion of mQMS-related training before going live/effective (Just in time).
  • Supporting for controlling GxP/QMS documents/ templates i.e. upload documents, update, retire documents in eDMS (DiaDoc), publish in RDTH Library share drive.
  • Supporting for conducting quality events, workshops etc. ie. meeting room reservation, contact with external suppliers for ordering gimmicks for promotion, etc.
  • Supporting follow-up with related departments for Deviation reports (NCs) and Corrective actions of internal stakeholders and Suppliers, Distributors (external) and SCARs as per timeline until closing.
  • Supporting a team in managing and filing Change Control Reports and related evidence from Process owners and support to follow up with related departments for change control implementation until closing.
  • Supporting document translation / reviewing from global translation as required.
  • Attending local/global QA-related meetings and getting messages for actions as required.
  • Supporting the team for other GxP/QMS-related activities as required.
  • Supplier Management
  • Supporting to find the qualified vendors for the required related services/products and support to create new vendors in the Purchasing system.
  • Reviewing identified Supplier critical risk levels from owners and Periodic evaluation risk levels based on performance and internal and external requirements.
  • Document control
  • Filing and archiving GxP/QMS documents/records as the company required a retention period.
  • Supply Chain Quality
  • Working closely with the Supply Chain team and 3rd party warehouse for reading and qualifying the data logger results in the system for incoming shipments, and informing results for releasing/holding products to relevant functions.
  • Creating data loggers in a Cold stream system and sending them to 3rd party warehouse for putting data loggers into the export shipments to Indo-China.
  • Collaborating with the Supply Chain team and global quality supply chain for investigation of the temperature excursion case to find the root cause and CAPA.
  • Supporting a team in releasing the returned products (CN) to the appropriate location and filing the return documents.
  • Supporting team for change control, audit/evaluation of new 3rd party warehouse, critical suppliers etc. according to the company's standards.
  • Training Administration
  • Acting as a learning expert to support the QA team for the relevant GxP/QMS training i.e. Open tickets to request training curriculums, create sessions in the LMS system and Report downloading, Monitor completion of employees etc. according to the Global Standard Process - Training's requirement.
  • Indo-China (Cambodia, Laos)
  • Supporting team for control quality processes of distributors at Indo-China (Cambodia, Laos) of DIA and DC i.e. training, monitoring NCs, CAPA, return and destruction process as required.
To be successful in this role, our new team member will be able to demonstrate the following:
  • Education: Bachelor's degree in Science or other related fields.
  • At least 1-2 years of experience in Quality Assurance, Quality Control in the Biotech or Pharmaceutical industry or related fields.
  • Good command of listening, written and spoken English skills or TOEIC score
550. * Good computer skills in Word, Powerpoint, Excel i.e. V-look, Pivot and Google form etc.
  • Work with multiple stakeholders internally and externally.
  • Strong multitasking and interpersonal skills.
  • Positive attitude and willingness to learn new things.
  • Sense of urgency and confidentiality.
  • Ability to work in a dynamic environment, managing multiple deadlines and priorities.
  • Team-oriented, actively participating and sharing opinions.

PRTR